- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03992690
Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peng-Hu Wei, M.D.
- Phone Number: 00861083198252
- Email: weipenghu@xwhosp.org
Study Locations
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Beijing
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Beijing, Beijing, China, 100053
- Recruiting
- Xuanwu Hospital, Capital Medical University
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Contact:
- Peng-Hu Wei, M.D.
- Phone Number: 010-83198836 010-83198899
- Email: weipenghu@xwhosp.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1. Discomplete spinal cord injury;
- 2. Traumatic etiology;
- 3. American Spinal Injury Association Impairment Scale(ASIA) A grade;
- 4. The level of SCI in T9-T12;
- 5. ≥12 months post injury;
- 6. Considered independents to perform daily life activities: feeding, dressing, capability with wheelchair;
- 7. Emotional stability;
Exclusion Criteria:
- 1. Absence of SCI, or presence of multi-segmental injury;
- 2. SCI non-traumatic etiology;
- 3. Age<18 years or Age>60 years;
- 4. Emotional instability;
- 5. Unavailable time to join the protocol activities;
- 6. Already enrolled in other research protocol;
- 7. Acute or chronic decompensated comorbidities (e.g. Hypertension, Diabetes, cardiomyopathy, chronic respiratory insufficiency, chronic renal insufficiency, hepatopathy, or any other neurological disorders besides the SCI);
- 8. Alcohol/drugs abuse and dependence;
- 9. Psychiatric disorders (exception: treated depression);
- 10.Cognitive deficit; visual deficit; auditory deficit;
- 11. Incapacitating pain;
- 12. Pregnancy;
- 13. Presence of limb amputations (exception: hand distal phalanges);
- 14. Peripheral neuropathy associated (e.g.: brachial plexus injury, carpal tunnel syndrome);
- 15. Muscle injury associated (e.g. myotendinous rupture, burning injury, muscle-compartment syndrome);
- 16. Neuromuscular disease associated (ex: myopathy) or lower limb fractures within the past six months;
- 17. Movement disorders(e.g. ataxia);
- 18. Use of medication that can negatively impact on neurological/motor recovery;
- 19. Presence of joint deformities, presence of fractures;
- 20. Lower limb spasticity MAS (Modified Ashworth Scale)>2;
- 21. Pressure ulcer: considering grade 3 or 4, injury size and body location;
- 22. Cephalic metallic /magnetic implants (exception: MRI compatible implants);
- 23. Presence of cardiac or neural pacemaker;
- 24. Use of devices/tubes: tracheostomy, gastrostomy, nasogastric, long-term bladder catheterization, cystostomy, colostomy, totally implanted catheter system, arteriovenous dialysis fistula;
- 25. Severe osteoporosis (Tscore>-4);
- 26. Syringomyelia;
- 27. Lokomat or ZeroG training within the prior 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: WANR protocol
Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion
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Training integrating virtual-reality avatar driven by a brain-machine interface, with tactile feedback through patient's forearms, and assisted locomotion, for neurorehabilitation of SCI patients.
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ACTIVE_COMPARATOR: Classical physiotherapy protocol
Training with classical physiotherapy protocol
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Stretching
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point
Time Frame: After nine-months of training
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The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function) for 5 lower extremity muscle groups with a 50-point maximum (25 per side)
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After nine-months of training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of nociception improvement: ASIA pin-prick sensory score
Time Frame: After nine-months of training
|
Testing of a key point in each of the 28 dermatomes (from C2 to S4-5) on the right and left sides of the body that can be readily located in relation to bony anatomical landmarks. At each of these key points, sensation of pin prick is examined: Appreciation of pin prick sensation at each of the key points is separately scored on a three-point scale, with comparison to the sensation on the patients' cheek as a normal frame of reference: 0 = absent 1= altered (impaired or partial appreciation, including hyperesthesia) 2 = normal or intact (similar as on the cheek) NT = not testable The maximum scale is 112 |
After nine-months of training
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Improvement of Walking index for SCI (WISCI)
Time Frame: After nine-months of training
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The subject is observed by the trained personnel and the WISCI level is recorded on the scale of 0 to 20 at baseline (Baseline WISCI).
The subject is observed again at the defined interval (Interval WISCI).
The change in score is calculated by subtracting the baseline WISCI from the Interval WISCI, which equals the change in WISCI (Changed WISCI).
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After nine-months of training
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Change of WHO-QoL bref
Time Frame: After nine-months of training
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The WHOQOL-BREF questionnaire contains two items from the Overall QOL and General Health and 24 items of satisfaction that divided into four domains.
Raw domain scores for the WHOQOL were transformed to a 4-20 score according to guidelines
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After nine-months of training
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Change of post-void residual urine
Time Frame: After nine-months of training
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Usually, the value is less than 50 ml.
A post-void residual urine greater than 50 ml is a significant amount of urine and increases the potential for recurring urinary tract infections.
In adults older than 60 years, 50-100 ml of residual urine may remain after each voiding because of the decreased contractility of the detrusor muscle
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After nine-months of training
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guo-Guang Zhao, M.D., Xuanwu Hospital, Beijing
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XW-[2019]-023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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